Prostate CancerNCT01699672
Group-based or Individual Information About Disease and Treatment Plan
A study testing Group information in people with Prostate Cancer and Breast Cancer, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The main aim of the current study is to investigate whether the addition of a standardized,group-based educational program to the information provided by health care personnel improves cancer patients' knowledge level about their disease, planned treatment and common side-effects of the treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Breast Cancer
- What is being tested?
- Group information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2012to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer patients that are candidates for adjuvant chemotherapy after surgery.
- Prostate cancer patients that are candidates for curative radiotherapy
- Signed informed consent
- Patient expected to be able to complete the planned treatment and the study procedures
- 18years or older
Who cannot join
- -Patients not fulfilling inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cancer Patients' Knowledge and Satisfaction After Group-based or Individual Information About Their Disease and Treatment Plan
The main aim of the current study is to investigate whether the addition of a standardized,group-based educational program to the information provided by health care personnel improves cancer patients' knowledge level about their disease, planned treatment and common side-effects of the treatment.
Secondary aims are to investigate if the addition of the educational program increases the likelihood of completing treatment as planned, reduces level of anxiety, reduces the frequency of serious side effects, increases patient reported health related quality of life, and increases the degree of patient satisfaction with respect to how they have received the information before, during and after treatment.
Read the detailed description
There are strong indications that group-based information provides better information for cancer patients about their disease, treatment options - and potential benefits and side effects of the planned therapy than information provided during a regular doctor consultation.
The investigators believe that standardizing and repeating the information as well as having more time for questions in an open environment for reflections will improve the amount of information patients can perceive. Furthermore, all patients will be given written information.
Better-informed patients may be more motivated and may contact health care personnel earlier than other patients when they develop side effects. This may reduce the risk of serious treatment-related complications and increase the chances of patients completing the planned treatment. But none have compared to what extent an organization like Vardesenteret improves the patients' knowledge and whether patients are more satisfied with these methods for informing them. Results from studies on the influence of patient anxiety and distress on patient's abilities to perceive information are conflicting.Two large groups of relatively homogenous cancer patients are patients with lower-stage breast cancer patients who are eligible for adjuvant chemotherapy and patients with localized prostate cancer eligible for curative radiotherapy.
- Conditions
- Prostate Cancer, Breast Cancer
- Being tested
- Group information
- Keywords
- Patient education, information, communication
- Medical subject headings
- Prostatic Neoplasms, Breast Neoplasms, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group informationOther
The patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses.
| Study group | Role | What they receive |
|---|---|---|
| Group and Individual information | Experimental | The patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses. Receives: Other: Group information |
| Individual information | No intervention | Standard information about disease and treatment from doctor and nurse given at 2 occasions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge
Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.
Measured: 1 week
Knowledge
Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.
Measured: 2 weeks
Knowledge
Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.
Measured: 9 weeks
Secondary outcomes (9)
Quality of Life
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire C30
Measured: 9 weeks
Patients Subjective state of information
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
Measured: 1 week
Patients Subjective state of information
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
Measured: 2 weeks
Patients Subjective state of information
European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire INFO 25
Measured: 9 weeks
Anxiety
STAI-State and Trait Anxiety Inventory
Measured: 1 week
Anxiety
STAI-State and Trait Anxiety Inventory
Measured: 2 weeks
Anxiety
STAI-State and Trait Anxiety Inventory
Measured: 9 weeks
Adverse events
CTCEA, Common Terminology Criteria for Adverse Events
Measured: 2 weeks
Adverse events
CTCEA, Common Terminology Criteria for Adverse Events
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Problems recruiting patients (not willing, travel time, no respons)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Stein Kaasa, MD, Prof., Principal investigator, St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research CenterOla Berger, MD, Study director, St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research CenterBjørn H Gønberg, MD, PhD, Study chair, St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research CenterKari Sand, Cand Philol, Study chair, PRC, European Palliative Care Research CenterJo Å Lund, MD, PhD, Study chair, St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research CenterJon H Loge, MD, Prof., Study chair, National Resource Centre for Studies of Late Effects after Cancer Treatment, Oslo University Hospital, Radiumhospitalet, Oslo, Norway; Department of Behavioral Sciences in Medicine, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699672
- Sponsor's protocol ID
- REK2012/1238
- Status last verified
- Jan 2017
- First submitted
- 21 Sep 2012
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Berger O, Gronberg BH, Loge JH, Kaasa S, Sand K. Cancer patients' knowledge about their disease and treatment before, during and after treatment: a prospective, longitudinal study. BMC Cancer. 2018 Apr 3;18(1):381. doi: 10.1186/s12885-018-4164-5.
PubMed 29614997
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Patients' Knowledge and Satisfaction After Group-based or Individual Information About Their Disease and Treatment Plan
- ClinicalTrials.gov ID
- NCT01699672
- Acronym / sponsor ID
- REK2012/1238
- Conditions
- Prostate Cancer, Breast Cancer
- Keywords
- Patient education, information, communication
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Problems recruiting patients (not willing, travel time, no respons)
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Oct 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 4 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of the current study is to investigate whether the addition of a standardized,group-based educational program to the information provided by health care personnel improves cancer patients' knowledge level about their disease, planned treatment and common side-effects of the treatment.
Secondary aims are to investigate if the addition of the educational program increases the likelihood of completing treatment as planned, reduces level of anxiety, reduces the frequency of serious side effects, increases patient reported health related quality of life, and increases the degree of patient satisfaction with respect to how they have received the information before, during and after treatment.
Detailed description
There are strong indications that group-based information provides better information for cancer patients about their disease, treatment options - and potential benefits and side effects of the planned therapy than information provided during a regular doctor consultation.
The investigators believe that standardizing and repeating the information as well as having more time for questions in an open environment for reflections will improve the amount of information patients can perceive. Furthermore, all patients will be given written information.
Better-informed patients may be more motivated and may contact health care personnel earlier than other patients when they develop side effects. This may reduce the risk of serious treatment-related complications and increase the chances of patients completing the planned treatment. But none have compared to what extent an organization like Vardesenteret improves the patients' knowledge and whether patients are more satisfied with these methods for informing them. Results from studies on the influence of patient anxiety and distress on patient's abilities to perceive information are conflicting.Two large groups of relatively homogenous cancer patients are patients with lower-stage breast cancer patients who are eligible for adjuvant chemotherapy and patients with localized prostate cancer eligible for curative radiotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group and Individual information | Experimental | Other: Group informationThe patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses. |
| Individual information | No intervention | –Standard information about disease and treatment from doctor and nurse given at 2 occasions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Breast cancer patients that are candidates for adjuvant chemotherapy after surgery.
- Prostate cancer patients that are candidates for curative radiotherapy
- Signed informed consent
- Patient expected to be able to complete the planned treatment and the study procedures
- 18years or older
Key exclusion criteria (1 listed)
- -Patients not fulfilling inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group informationThe patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses. | Other | Group and Individual information |
Primary outcome
Knowledge
Time frame: 1 week
Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.
Knowledge
Time frame: 2 weeks
Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.
Knowledge
Time frame: 9 weeks
Knowledge questionnaires specially made for the study. Constructed as statements with response categories; correct, false and don´t know.
9 secondary outcomes
Quality of Life
Time frame: 9 weeks
Patients Subjective state of information
Time frame: 1 week
Patients Subjective state of information
Time frame: 2 weeks
Patients Subjective state of information
Time frame: 9 weeks
Anxiety
Time frame: 1 week
Anxiety
Time frame: 2 weeks
Anxiety
Time frame: 9 weeks
Adverse events
Time frame: 2 weeks
Adverse events
Time frame: 9 weeks
Results and safety
The study was stopped early (reason given: Problems recruiting patients (not willing, travel time, no respons)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- Derived from this study: PubMed 29614997Berger O, Gronberg BH, Loge JH, Kaasa S, Sand K. Cancer patients' knowledge about their disease and treatment before, during and after treatment: a prospective, longitudinal study. BMC Cancer. 2018 Apr 3;18(1):381. doi: 10.1186/s12885-018-4164-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stein Kaasa, MD, Prof. principal investigator
St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
Ola Berger, MD study director
St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
Bjørn H Gønberg, MD, PhD study chair
St Olavs Hospital - Trondheim University Hospital and PRC, European Palliative Care Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group information in people with Prostate Cancer and Breast Cancer, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Problems recruiting patients (not willing, travel time, no respons)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01699672, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017.